Clinical Data Specialist

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine. Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster. Responsible for the review of all source data and ensure all applicable data is entered into its respective database and/or Case Report Form (CRF). Ensure the completeness, accuracy, and consistency of source data and CRF data entry so that it meets the standard of quality expected for reporting to Sponsors and regulatory bodies. Participate with auxiliary teams involved in study set up, conduct, and data cleaning of clinical trials. Essential Functions: - Attend study setup meetings to determine QC criteria and timelines for each study - Review study-specific source documents to ensure all forms are accurate prior to study start and that all data collected is in accordance with study-specific Case Report Forms and protocol requirements. - Ensure QC reviews are complete in accordance with study-specific timelines - Review source data on an ongoing basis to ensure the following: Clinical source data is complete according to GCP and FDA guidelines, protocol deviations (if applica...